Ketorolac and Pregabalin Effects on breaSt Cancer (KePreSt)
Out of all proportion to its short duration, the perioperative period is critical in determining the long-term outcome of cancer. To contribute to a better understanding of the neural and inflammatory mechanisms underlying this issue, we aim to implement a novel intervention based on the preoperative use of non-steroid
| Condition(s) | Early-stage Breast Cancer, Estrogen-receptor-positive Breast Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | Out of all proportion to its short duration, the perioperative period is critical in determining the long-term outcome of cancer. To contribute to a better understanding of the neural and inflammatory mechanisms underlying this issue, we aim to implement a novel intervention based on the preoperative use of non-steroidal anti-inflammatory drugs (NSAIDs) with or without an anti-epileptic drug. Our goal is to understand and transform the perioperative window from being a facilitator of metastatic progression to arresting and/or eliminating residual disease using repurposing drugs |
| Who can participate | Inclusion Criteria: Subjects must meet all of the following criteria in order to be eligible for this study: 1. Age ≥ 18 years and ≤ 70 years old 2. Female 3. Weight ≥ 35 kg 4. Histological diagnosis of invasive breast adenocarcinoma that is estrogen receptor positive as per the updated American Society of Clinical Oncology (ASCO) - College of American Pathologists (CAP) guidelines according to local testing with ER-positive is defined as having an immunohistochemistry (IHC) of 1% or more and/or Allred score of 3 or more 5. Tumour size ≥ 1.5 cm, determined by diagnostic ultrasound or MRI/CT scan. 6. Stage I, II or III disease (non-metastatic) 7. In case of multifocal, multicentric unilateral or bilateral breast: Adenocarcinoma tumours are allowed provided that all foci are ER+ according to |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Lead sponsor | Jules Bordet Institute |
| Locations | Brussels, Brussels Capital, Belgium |
| Start date | 2025-05-12 |
| NCT ID | NCT06150898 |
| Official listing | https://clinicaltrials.gov/study/NCT06150898 |